The Food and Drug Administration said on Monday that vaccine developers would not be required to conduct long-term randomized controlled trials for vaccines that have been adapted to protect against coronovirus variants.
The recommendations, which favor the small tests required for annual flu vaccines, will greatly speed up the review process at a time when scientists are concerned about how slow or reverse progress can be made against the virus. .
The guidance was part of a slate of new documents released on Monday, addressing others about how antibiotic treatments and clinical trials may need to be withdrawn to respond to virus treatments.
Together, they gave the federal government the most detailed acknowledgment of the threat to treatment and testing for the current vaccine, coronovirus, and FDA acting commissioner Dr. Janet Woodcock said the agency was developing a plan.
“The emergence of virus variants creates new concerns about the performance of these products,” Woodcock said in a statement on Monday. “We want the American public to know that we are using every tool in our toolbox to fight this epidemic, including adapting viruses.”
Most vaccine manufacturers authorized vaccines or candidates in late-stage trials have already announced plans to adjust their products to address vaccine variants. Modern and Pfizer-Bayonetec vaccines use mRNA technology that companies have said can be used to replace existing vaccines within six weeks, although testing and manufacturing will take longer.
Modern has already started developing a new version of its vaccine that can be used as a booster shot against a virus variant originating in South Africa, known as B.1.351 , Which reduces the effectiveness of existing vaccines.
A fast-spreading coronavirus variant first seen in the UK has also acquired a worrying mutation that can make vaccines difficult to control. This variant was found in the United States with the mutation last week.
Nevertheless, the guidance is not written with the assumption that new vaccines were imminent, or would be needed. Despite recent indications that some variants – and especially B.1.351 – make currently authorized vaccines less effective, shots still provide protection and appear to reduce the severity of the disease, leading to hospitalization Recruitment and death can be prevented.
At a news briefing on Monday afternoon, how much the variants would have to spread before the updated vaccine became necessary, Drs. Woodcock did not provide any specific criteria. “We need to anticipate and work on it so that we have something in our back pocket before it is on us,” she said.
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An updated COVID-19 vaccine may skip the months-long process of a randomized clinical trial that would compare with a placebo. But a vaccine containing a vaccine will still have to undergo some testing. In tests proposed by the FDA, researchers will draw blood A relatively small group of Volunteers who have been given customized vaccines. Scientists will then observe how many percent of samples of volunteers produce an immune response to variants in the laboratory, and how large this response is. Vaccines will be considered acceptable if they produce an immune response that is close to the one induced by the original vaccines.
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The FDA’s top vaccine regulator, Dr. Peter Marks said at the news briefing that the studies would include “a few hundred” people and the last several months.
Volunteers will also be carefully monitored for side effects. The agency stated that the test could be done in the same age group and then additional to other age groups.
The guidance encouraged the use of animal studies to support the case for modified vaccines, in which case immune response studies come up with unclear conclusions.
The FDA acknowledged that many questions remained unanswered, such as what kind of data would trigger the need for a customized vaccine and who would make the decision. The agency also said that scientists have not determined the minimum level of antibodies in the blood of the vaccinated person that would protect someone from the virus.
Some other vaccines are regularly updated in a similar way. Because the influenza virus develops rapidly from one year to the next, vaccine developers have to come up with new recipes annually.
Regulators said the newly created COVID-19 vaccines would be authorized under the amendment of the emergency authority given for the original vaccine.